ISO 13485:2016 Introduction Training course

This course explores the requirements of the ISO 13485:2016 Quality Management System standard, discussing key principles and how the standard interacts with ISO 9001:2015, the European Medical Device Directives and US FDA’s Quality System Regulation. The relationship with ISO 14971 ‘Application of Risk Management to Medical Devices’ is also explored during the course.

Delegates gain a better insight into the use of ISO 13485:2016 as the basis for a Quality Management System (QMS) implemented by medical device manufacturers.


Who should attend?

Senior management, quality managers, regulatory affairs managers, internal and external auditors, consultants and anyone involved with the implementation of the standard.

Prerequisites:

There are no formal prerequisites, however it will be useful for delegates to read the standard before attending the course.

By the end of this course delegates will be able to:

  • Explain the use of ISO 13485:2016 as the basis for a QMS for medical device manufacturers
  • Identify the relationship between ISO 13485:2016 and European Medical Device Directives
  • Recognize the use of ISO 13485:2016 as the basis of regulatory requirements worldwide

Practical information

  • It's a 1-day course
  • The training and materials will be provided in English
  • Lunch and drinks are included

For further information regarding reduced rates at the hotel where the training is being conducted please contact training.nl@bsigroup.com or 0031-(0)20-3460783.

ISO 13485:2016 learning path and combination discount

The ISO 13485:2016 Introduction learning path is modular. You can follow the training in all combinations. We recommend the following order:

Leerroute

Besides this introduction course, are the following training courses also part of the ISO 13485 learning path:

2. Implementation

3. Internal Auditor

4. Lead Auditor

Attending several training courses of a learning path is associated with special discounts. 

No.

Training

Price

 

1

 Introduction ISO 13485:2016

    € 675

 

2

 Implementation ISO 13485:2016

    € 1.350

 

3

 Internal Auditor ISO 13485:2016

    € 1.350

 

4

 Lead Auditor ISO 13485:2016

    € 3.200

 

 

 Total

    € 6.575

 

 

 

 

 

 

 

 Investment

 Discount

 

 Combination training 1 + 2 

€ 1.925

€ 100

 

 Combination training 1 + 3

€ 1.925

€ 100

 

 Combination training 1 + 4

€ 3.700

€ 175

 

 Combination training 1 + 2 + 3

€ 3.150

€ 225

 

 Combination training 1 + 2 + 3 + 4

€ 6.175

€ 400

If more employees need to understand, implement, audit, your management system, training can be delivered at your location. Based on your learning needs we could provide a customized in-house training course for your team.  

For more information about the learning path or in-house training courses, please contact Mark Leenaers via +31 20 346 07 83 or send an email to mark.leenaers@bsigroup.com.


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